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1 dose (1.5 ml)
The vaccination course consists of two doses. The first dose may be administered from the age of 6 weeks. There should be an interval of at least 4 weeks between doses. The vaccination course should preferably be given before 16 weeks of age, but must be completed by the age of 24 weeks. Rotarix may be given with the same posology to preterm infants born after at least 27 weeks of gestational age.
In clinical trials, spitting or regurgitation of the vaccine has rarely been observed and, under such circumstances, a replacement dose was not given. However, in the unlikely event that an infant spits out or regurgitates most of the vaccine dose, a single replacement dose may be given at the same vaccination visit. It is recommended that infants who receive a first dose of Rotarix complete the 2-dose regimen with Rotarix. There are no data on safety, immunogenicity or efficacy when Rotarix is administered for the first dose and another rotavirus vaccine is administered for the second dose or vice versa.
Paediatric population: Rotarix should not be used in children over 24 weeks of age.
Active immunisation of infants from the age of 6 weeks for prevention of gastro-enteritis due to rotavirus infection.
Hypersensitivity, hypersensitivity after previous administration. Previous history of intussusception. Uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception. Infants who have known or suspected immunodeficiency. Administration to asymptomatic HIV subjects is not recommended. Administration should be postponed in subjects suffering from acute severe febrile illness, diarrhea or vomiting. Minor infection is not a contra-indication for immunisation. Should under no circumstances be injected.
It is good clinical practice that vaccination should be preceded by a review of the medical history especially with regard to the contraindications and by a clinical examination. There are no data on the safety and efficacy of Rotarix in infants with gastrointestinal illnesses or growth retardation. Administration of Rotarix may be considered with caution in such infants when, in the opinion of the physician, withholding the vaccine entails a greater risk. No increased risk of intussusception was observed in clinical trials following administration of Rotarix when compared with placebo. However, a small increased risk of intussusception in the 31-day period mostly within 7 days following the administration of the first dose of Rotarix cannot be excluded based on data from postmarketing safety studies. Therefore, as a precaution, healthcare professionals should follow-up on any symptoms indicative of intussusception (severe abdominal pain, persistent vomiting, bloody stools, abdominal bloating and/or high fever). Parents/guardians should be advised to promptly report such symptoms. For subjects with a predisposition for intussusception.Asymptomatic and mildly symptomatic HIV infections are not expected to affect the safety or efficacy of Rotarix. A clinical study in a limited number of asymptomatic or mildly symptomatic HIV positive infants showed no apparent safety problems. Administration of Rotarix to infants who have known or suspected immunodeficiency should be based on careful consideration of potential benefits and risks. Excretion of the vaccine virus in the stools is known to occur after vaccination with peak excretion around the 7th day. Viral antigen particles detected by ELISA were found in 50% of stools after the first dose of Rotarix lyophilised formulation and 4% of stools after the second dose. When these stools were tested for the presence of live vaccine strain, only 17% were positive. In two comparative controlled trials, vaccine shedding after vaccination with Rotarix liquid formulation was comparable to that observed after vaccination with Rotarix lyophilised formulation. Cases of transmission of this excreted vaccine virus to seronegative contacts of vaccinees have been observed without causing any clinical symptom. Rotarix should be administered with caution to individuals with immunodeficient close contacts, such as individuals with malignancies, or who are otherwise immunocompromised or individuals receiving immunosuppressive therapy. Contacts of recent vaccinees should observe personal hygiene (e.g. wash their hands after changing child’s nappies). A protective immune response may not be elicited in all vaccinees. The extent of protection that Rotarix might provide against other rotavirus strains that have not been circulating in clinical trials is currently unknown. Clinical studies from which efficacy data were derived were conducted in Europe, Central and South America, Africa and Asia. Rotarix does not protect against gastro-enteritis due to other pathogens than rotavirus. No data are available on the use of Rotarix for post-exposure prophylaxis. Rotarix should under no circumstances be injected. The vaccine contains sucrose as an excipient. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this vaccine. This vaccine contains 32 mg sodium per dose. To be taken into consideration by patients on a controlled sodium diet.
For full details see prescribing information.
Summary of the safety profile: The safety profile presented below is based on data from clinical trials conducted with either the lyophilised or the liquid formulation of Rotarix. In a total of four clinical trials, approximately 3800 doses of Rotarix liquid formulation were administered to approximately 1900 infants. Those trials have shown that the safety profile of the liquid formulation is comparable to the lyophilised formulation. In a total of twenty-three clinical trials, approximately 106000 doses of Rotarix (lyophilised or liquid formulation) were administered to approximately 51000 infants. In three placebo-controlled clinical trials (Finland, India and Bangladesh), in which Rotarix was administered alone (administration of routine paediatric vaccines was staggered), the incidence and severity of the solicited events (collected 8 days post-vaccination), diarrhoea, vomiting, loss of appetite, fever, irritability and cough/runny nose were not significantly different in the group receiving Rotarix when compared to the group receiving placebo. No increase in the incidence or severity of these events was seen with the second dose. In a pooled analysis from seventeen placebo-controlled clinical trials (Europe, North America, Latin America, Asia, Africa) including trials in which Rotarix was co-administered with routine paediatric vaccines, the following adverse reactions (collected 31 days post-vaccination) were considered as possibly related to vaccination.
For full details see prescribing information.
Rotarix can be given concomitantly with any of the following monovalent or combination vaccines [including hexavalent vaccines (DTPa-HBV-IPV/Hib)]: diphtheria-tetanus-whole cell pertussis vaccine (DTPw), diphtheria-tetanus-acellular pertussis vaccine (DTPa), Haemophilus influenzae type b vaccine (Hib), inactivated polio vaccine (IPV), hepatitis B vaccine (HBV), pneumococcal conjugate vaccine and meningococcal serogroup C conjugate vaccine. Clinical studies demonstrated that the immune responses and the safety profiles of the administered vaccines were unaffected.
Concomitant administration of Rotarix and oral polio vaccine (OPV) does not affect the immune response to the polio antigens. Although concomitant administration of OPV may slightly reduce the immune response to rotavirus vaccine, clinical protection against severe rotavirus gastro-enteritis was shown to be maintained in a clinical trial involving more than 4200 subjects who received Rotarix concomitantly with OPV. There are no restrictions on the infant’s consumption of food or liquid, either before or after vaccination.
Pregnancy and Lactation
Rotarix is not intended for use in adults. There are no data on the use of Rotarix during pregnancy and lactation.
Based on evidence generated in clinical trials, breast-feeding does not reduce the protection against rotavirus gastro-enteritis afforded by Rotarix. Therefore, breast-feeding may be continued during the vaccination schedule.
No case of overdose has been reported.